Methods and devices for capturing and fixing leaflets in valve repair

ABSTRACT

The present invention provides methods and devices for grasping, and optional repositioning and fixation of the valve leaflets to treat cardiac valve regurgitation, particularly mitral valve regurgitation. Such grasping will typically be atraumatic providing a number of benefits. For example, atraumatic grasping may allow repositioning of the devices relative to the leaflets and repositioning of the leaflets themselves without damage to the leaflets. However, in some cases it may be necessary or desired to include grasping which pierces or otherwise permanently affects the leaflets. In some of these cases, the grasping step includes fixation.

CROSS-REFERENCES TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.14/698,470, filed Apr. 28, 2015, which is a divisional of U.S. patentapplication Ser. No. 13/216,385, filed Aug. 24, 2011 (now U.S. Pat. No.9,044,246), which is a continuation of U.S. patent application Ser. No.11/928,403, filed Oct. 30, 2007 (now U.S. Pat. No. 8,029,518), which isa continuation of U.S. patent application Ser. No. 10/803,444, filedMar. 17, 2004 (now U.S. Pat. No. 7,563,273), which is a continuation ofU.S. patent application Ser. No. 09/894,463, filed Jun. 27, 2001 (nowU.S. Pat. No. 6,752,813), the full disclosures of which are herebyincorporated herein by reference.

BACKGROUND OF THE INVENTION 1. Field of the Invention

The present invention relates generally to medical methods, devices, andsystems. In particular, the present invention relates to methods,devices, and systems for the endovascular or minimally invasive surgicalrepair of the valves of the heart, particularly the mitral valve.

Mitral valve regurgitation can result from a number of differentmechanical defects in the mitral valve. The valve leaflets, the valvechordae which connect the leaflets to the papillary muscles, or thepapillary muscles themselves may be damaged or otherwise dysfunctional.Commonly, the valve annulus may be damaged, dilated, or weakenedlimiting the ability of the mitral valve to close adequately against thehigh pressures of the left ventricle.

Mitral valve regurgitation can result from a number of differentmechanical defects in the mitral valve. The valve leaflets, the valvechordae which connect the leaflets to the papillary muscles, or thepapillary muscles themselves may be damaged or otherwise dysfunctional.Commonly, the valve annulus may be damaged, dilated, or weakenedlimiting the ability of the mitral valve to close adequately against thehigh pressures of the left ventricle.

The most common treatments for mitral valve regurgitation rely on valvereplacement or strengthening of the valve annulus by implanting amechanical support ring or other structure. The latter is generallyreferred to as valve annuloplasty. A recent technique for mitral valverepair which relies on suturing adjacent segments of the opposed valveleaflets together is referred to as the “bow-tie” or “edge-to-edge”technique. While all these techniques can be very effective, theyusually rely on open heart surgery where the patient's chest is opened,typically via a sternotomy, and the patient placed on cardiopulmonarybypass. The need to both open the chest and place the patient on bypassis traumatic and has associated morbidity.

For these reasons, it would be desirable to provide alternative andadditional methods, devices, and systems for performing the repair ofmitral and other cardiac valves, particularly the tricuspid and aorticvalves. Such methods, devices, and systems should preferably not requireopen chest access and be capable of being performed eitherendovascularly, i.e., using devices which are advanced to the heart froma point in the patient's vasculature remote from the heart or by aminimally invasive approach. Still more preferably, the methods,devices, and systems should not require that the heart be bypassed,although the methods, devices, and systems should be useful withpatients who are bypassed and/or whose heart may be temporarily stoppedby drugs or other techniques. At least some of these objectives will bemet by the inventions described hereinbelow.

2. Description of the Background Art

Minimally invasive and percutaneous techniques for coapting andmodifying mitral valve leaflets to treat mitral valve regurgitation aredescribed in WO 98/35638; WO 99/00059; WO 99/01377; and WO 00/03759.

Maisano et al. (1998) Eur. J. Cardiothorac. Surg. 13:240-246; Fucci etal. (1995) Eur. J. Cardiothorac. Surg. 9:621-627; and Umana et al.(1998) Ann. Thorac. Surg. 66:1640-1646, describe open surgicalprocedures for performing “edge-to-edge” or “bow-tie” mitral valverepair where edges of the opposed valve leaflets are sutured together tolessen regurgitation. Dec and Fuster (1994) N. Engl. J. Med.331:1564-1575 and Alvarez et al. (1996) J. Thorac. Cardiovasc. Surg.112:238-247 are review articles discussing the nature of and treatmentsfor dilated cardiomyopathy.

Mitral valve annuloplasty is described in the following publications.Bach and Bolling (1996) Am. J. Cardiol. 78:966-969; Kameda et al. (1996)Ann. Thorac. Surg. 61:1829-1832; Bach and Bolling (1995) Am. Heart J.129:1165-1170; and Bolling et al. (1995) 109:676-683. Linear segmentalannuloplasty for mitral valve repair is described in Ricchi et al.(1997) Ann. Thorac. Surg. 63:1805-1806. Tricuspid valve annuloplasty isdescribed in McCarthy and Cosgrove (1997) Ann. Thorac. Surg. 64:267-268;Tager et al. (1998) Am. J. Cardiol. 81:1013-1016; and Abe et al. (1989)Ann. Thorac. Surg. 48:670-676.

Percutaneous transluminal cardiac repair procedures are described inPark et al. (1978) Circulation 58:600-608; Uchida et al. (1991) Am.Heart J. 121: 1221-1224; and Ali Khan et al. (1991) Cathet. Cardiovasc.Diagn. 23:257-262.

Endovascular cardiac valve replacement is described in U.S. Pat. Nos.5,840,081; 5,411,552; 5,554,185; 5,332,402; 4,994,077; and 4,056,854.See also U.S. Pat. No. 3,671,979 which describes a catheter fortemporary placement of an artificial heart valve.

Other percutaneous and endovascular cardiac repair procedures aredescribed in U.S. Pat. Nos. 4,917,089; 4,484,579; and 3,874,338; and WO91/01689.

Thoracoscopic and other minimally invasive heart valve repair andreplacement procedures are described in U.S. Pat. Nos. 5,855,614;5,829,447; 5,823,956; 5,797,960; 5,769,812; and 5,718,725.

BRIEF SUMMARY OF THE INVENTION

The present invention provides methods, devices, and systems for theendovascular repair of cardiac valves, particularly the atrioventricularvalves which inhibit back flow of blood from a heart ventricle duringcontraction (systole), most particularly the mitral valve between theleft atrium and the left ventricle. By “endovascular,” it is meant thatthe procedure(s) of the present invention are performed withinterventional tools and supporting catheters and other equipmentintroduced to the heart chambers from the patient's arterial or venousvasculature remote from the heart. The interventional tools and otherequipment may be introduced to the vasculature percutaneously, i.e.,through an access sheath placed through the skin, or may be introducedvia a surgical cut down, and then advanced from the remote access sitethrough the vasculature to the heart. Thus, the procedures of thepresent invention will generally not require penetrations made directlythrough the exterior heart muscle, i.e., myocardium, although there maybe some instances where penetrations will be made interior to the heart,e.g., through the interatrial septum to provide for a desired accessroute. While the procedures of the present invention will usually bepercutaneous and intravascular, many of the tools will find use inminimally invasive and open surgical procedures as well. In particular,the tools for repositioning the valve leaflets prior to attachment canfind use in virtually any type of procedure for modifying cardiac valvefunction.

Although the methods, devices, and systems of the present invention maybe used for the endovascular repair of any of the cardiac valves, themajority of the description will be in regards to the repair ofatrioventricular valves. The atrioventricular valves are located at thejunctions of the atria and their respective ventricles. Theatrioventricular valve between the right atrium and the right ventriclehas three valve leaflets (cusps) and is referred to as the tricuspid orright atrioventricular valve. The atrioventricular valve between theleft atrium and the left ventricle is a bicuspid valve having only twoleaflets (cusps) and is generally referred to as the mitral valve. Inboth cases, the valve leaflets are connected to the base of the atrialchamber in a region referred to as the valve annulus, and the valveleaflets extend generally downwardly from the annulus into theassociated ventricle. In this way, the valve leaflets open duringdiastole when the heart atria fills with blood, allowing the blood topass into the ventricle. During systole, however, the valve leaflets arepushed together and closed to prevent back flow of blood into the atria.Thus, the valve leaflets each have generally two planar surfaces, asurface facing the atrium which may be referred to as the atrial surfaceand a surface facing the ventricle which may be referred to as theventricular surface. Such terminology may be used with cardiac valveswhich do not straddle an atrium and a ventricle. In these cases, it isunderstood that such terminology may be used to suitably describe thecorresponding valve surfaces.

Alternatively, the surfaces of the valves may be described in relationto flow direction. For example, since valve leaflets each have twoplanar surfaces, a surface facing upstream may be referred to as theupstream surface and a surface facing downstream may be referred to asthe downstream surface. In the case of the mitral valve, the atrialsurface would be the upstream surface and the ventricular surface wouldbe the downstream surface. In the case of the aortic valve, theventricular surface would be the upstream surface and the surface facingthe aorta would be the downstream surface. Such terminology may be mostrelevant when considering the natural shape of the leaflets since theshape is more related to direction of flow than orientation of the valvein the heart.

Interventions according to the present invention are generally directedat the valve leaflets. It will be the general purpose of suchinterventions to modify the manner in which the valve leaflets coapt orclose during systole so that back flow or regurgitation is minimized orprevented. While the procedures of the present invention will be mostuseful with the atrioventricular valves, at least some of the toolsdescribed hereinafter may be useful in the repair of other cardiacvalves, particularly the aortic valve.

The methods of the present invention will usually include accessing apatient's vasculature at a location remote from the heart and advancingan interventional catheter having a capturing device through thevasculature to a location near a cardiac valve to be repaired. Themethods may include applying an upward force against a downstreamsurface of at least one leaflet of the cardiac valve with the capturingdevice. Such application of force will reposition at least one leafletso as to reduce leakage through the valve during ventricular systole.Typically, two or more leaflets are repositioned in this manner toachieve desired coaptation. The interventional tool may comprise anelongate shaft having a proximal end and a distal end wherein thecapture device is disposed near the distal end. The capture device maycomprise at least one distal element capable of protruding radiallyoutward from the shaft. The above described application of force may beachieved by pressing a distal element of the capture device against thedownstream surface of the leaflet.

In a first aspect of the methods of the present invention, the distalelement may be adjusted prior to or after pressing the distal elementagainst the surface of the leaflet. Such adjustment may includeadjusting the length of protrusion of the distal element from the shaft.This may be achieved by retracting or extending the distal element. Thisallows the capture device to be advanced to the valve in a low profilearrangement and the distal elements to be extended for use once thecapture device has been positioned in a desired orientation in relationto the valve. When adjustment of the length is performed after thedistal element is in contact with the valve leaflet, such adjustment mayserve to reposition the valve leaflet. In addition, adjustment mayinclude adjusting the curvature of the distal element. Adjustment of thecurvature may also be achieved by retracting or extending the distalelement. Again, if this adjustment step is performed after the distalelement is in contact with the leaflet, such adjustment in curvature mayserve to reposition the valve leaflet. In some embodiments, the capturedevice may optionally comprise at least one proximal element capable ofprotruding radially outward from the shaft and the methods of thepresent invention may further include holding one or more leafletsbetween the proximal and distal elements. In this case, adjusting thelength and/or curvature of the proximal or distal elements may serve toreposition the captured valve leaflets. Such adjustment of the proximaland distal elements may be achieved simultaneously. In an additionalaspect, the proximal and distal elements may interlock for addedgrasping strength.

In a second aspect of the methods of the present invention, flow throughthe valve may be observed to determine if regurgitation has beeninhibited by the leaflet repositioning. Such observation may be achievedby any suitable means. If the regurgitation has not been sufficientlyinhibited, the application of upward force on at least one valve leafletwith the capturing device may be adjusted. This may be achieved with anyof the adjustment steps previously described and/or by decreasing orremoving any of the upward force against one or more valve leaflets. Theobservation and adjustment steps may be repeated any number of timesuntil the regurgitation has been sufficiently inhibited.

In a third aspect of the methods of the present invention, the leafletsmay optionally be fixed together. Fixing may include fastening,suturing, clipping, stapling, riveting, gluing, or fusing the leafletstogether. Alternatively, the capturing tool may be detached from theinterventional tool to serve as a fixation device. This involvesactivating a detachment or decoupling mechanism which allows the capturetool to separate from the interventional tool to be left behind as apermanent implant.

In a fourth aspect of the methods of the present invention, one or morevalve leaflets may be atraumatically captured with the capturing deviceand the captured leaflets may be repositioned independently of eachother. When the capture device comprises at least one distal elementcapable of protruding radially outward from the shaft, a leaflet may beatraumatically captured by pressing the distal element against theleaflet surface. The captured leaflets may be independently repositionedby independently adjusting the distal elements. Likewise, when thecapture device comprises at least one proximal element and one distalelement, each capable of protruding radially outward from the shaft, theatraumatically capturing step comprises holding the leaflet between theproximal and distal elements. The captured leaflets may be independentlyrepositioned by simultaneously retracting or extending the proximalelement and distal element disposed on opposite sides of the leaflet.Again, once the leaflets have been repositioned to a desiredorientation, the leaflets may be fixed together by any suitable meansincluding detaching the capture device from the interventional tool andleaving it behind.

In a fifth aspect of the methods of the present invention, the valveleaflets, each leaflet comprising a proximal side and a distal side, maybe repaired with the use of sutures having attached anchors. To begin, afirst leaflet may be penetrated from the proximal side to the distalside of the leaflet with a penetrating device. In this case, at least aportion of first anchor having a first attached suture is then deployedon the distal side of the first leaflet. A second leaflet is penetratedfrom the proximal side to the distal side with a penetrating device.Such a penetrating device may be the same penetrating device aspenetrated the first leaflet or a separate penetrating device. At leasta portion of a second anchor having a second attached suture is deployedon the distal side of the second leaflet. The first and second suturesare then secured together. By securing the sutures together, the valveis repaired by fixing the leaflets together in the desired coaptedorientation. Typically, the anchors are disposed in or on thepenetrating devices. For example, the anchors may be loaded within alumen in the penetrating devices or mounted externally on a penetratingdevice. In any case, the deploying steps comprise releasing the anchorsfrom the respective penetrating devices. In many cases, the anchors areexpanded to provide anchoring support on the distal side of the leafletto prevent the anchor from passing through the penetration and releasingthe suture. The anchors may be self-expanding or the deploying steps mayfurther comprise expanding the anchors.

As an alternative, anchors may be used simply to aid in the placement ofsutures wherein the anchors are removed prior to securing the suturestogether. In this case, again, a first leaflet is penetrated from theproximal side to the distal side of the leaflet with a penetratingdevice. And, at least a portion of a first anchor having a firstattached suture is deployed on the distal side of the first leaflet. Thefirst leaflet is again penetrated from the proximal side to the distalside with a penetrating device, however, this time at a new location. Atthis new location, a snare is deployed on the distal side of the leafletso that the snare captures at least part of the first anchor. The snareis then retracted so that the anchor is drawn through the penetration ofthe snare. By drawing the anchor through the penetration to the proximalside of the leaflet, the suture line effectively passes from theproximal side of the leaflet through a penetration to the distal sidetraversing a portion of the distal side of the leaflet and then passingthrough a separate penetration back to the proximal side of the leaflet.This may be repeated on a second leaflet in a similar manner. The fourportions of suture on the proximal side of the leaflets may then besecured together. This method may be repeated at any number of locationson the leaflet to create any number of suture lines on the proximal sideof the leaflet for securing together. Additional suture lines mayprovide added fixation strength or possible repositioning of theleaflets. Likewise, the anchor and snare may be deployed on separateleaflets, respectively, so that a suture line may penetrate a firstleaflet from the proximal side to the distal side traverse on the distalside of the leaflet to a second leaflet and then cross back through apenetration on the second leaflet to the proximal side. One or moresutures may be positioned in this manner and secured together aspreviously described. Also, it may be appreciated that such sutureplacement may be achieved on the opposite side of the leaflets so thatthe sutures are secured on the distal side of the leaflets.

The penetrating devices described above may be advanced through guideconduits on the interventional tool. Such guide conduits may be adjustedto direct the penetrating device toward the desired location on thevalve leaflet. Adjustment may include extending or retracting the guideconduits or angularly adjusting the guide conduits in relation to theshaft. When the capture device comprises at least one loop which isprotrudable radially outward from the shaft, the guide conduit may bepositioned so that the conduit guides the penetration device through theloop when the penetration device is advanced. Once the penetratingdevice has penetrated the leaflet, the loops may be retracted toradially translate the penetration devices and the penetrated leafletstoward the shaft. This may serve to reposition the leaflets in a moredesired coapted orientation.

The devices of the present invention will usually include aninterventional catheter configured to pass from the remote vasculatureof a patient to a position within the heart adjacent to the cardiacvalve to be repaired and a capture device on the interventional catheterfor capturing at least one valve leaflet. Typically, the capture deviceincludes at least one distal element and optionally includes at leastone proximal element. The distal end or proximal elements may becomprised of a number of materials, including wire, ribbon, filaments,or fibers which are made from stainless steel, metals, nitinol, shapememory alloy, polymers, silk, polyester or nylon, to name a few.

In a first aspect of the devices of the present invention, the distalelements of the capture devices may take a number of forms and theseforms can take a number of shapes. In a preferred embodiment, the distalelements have the form of loops. The loops may have a petal shape sothat when the loops are positioned on opposite sides of the shaft, theloops will form a “figure 8” shape when viewed from the top or bottom.This loop configuration is most suitable for use with valves having twoleaflets. It may be appreciated that more than two loops may be presentand arranged around the shaft having various distances between theloops. Thus, the looped distal elements may be configured for valveshaving three leaflets. In another embodiment, the distal element has theform of a block, rod or bar disposed perpendicularly to the shaft. Thebar may pivot around a pivot point at the base of the shaft tomanipulate the position of the bar. Such manipulation may be achievedwith the use of a pullwire extending from the shaft to the bar.Retracting or pulling upwards on the pullwire may pivot the bar aroundthe pivot point. Such pivoting orients the bar to a low profile positionso that the interventional tool may more easily be passed through aguide catheter, and further between a set of valve leaflets so that thebar is disposed below the valve. The bar may then be pressed against thedownstream surface of the leaflets to grasp and reposition the leaflets.

In a second aspect of the devices of the present invention, the distalelements may be individually repositionable or adjustable. The elementsmay be extended or retracted by variable amounts for protrusion ofvarious distances from the shaft. Such extension and retraction may alsoadjust the width of the exposed elements if the width varies radiallyfrom the shaft, such as with a petal shape. Further, the elements mayhave differing angles of curvature. This may be achieved by heat-shapingthe elements to have different curvatures, or the curvatures may beadjusted by manipulation by the user. Individual manipulation of theelements allows individually protruding the elements prior to capturingthe leaflets to ensure proper orientation and includes individuallyadjusting the elements after grasping the leaflets to reposition theleaflets. In addition, it may be appreciated that the elements may beextended and retracted simultaneously, if desired.

In a third aspect of the devices of the present invention, theinterventional tool comprises proximal elements which are capable ofprotruding radially outward from the shaft at a location which isproximal to the distal elements. The proximal elements may have any ofthe forms, shapes, material compositions, features or capabilitiesdescribed in relation to the distal elements. Thus, the proximalelements may be extended, retracted or similarly adjusted to furtherorient the captured leaflets. The proximal elements may be deployedseparately from the distal elements. For example, the proximal elementsmay be constrained within a shaft while the distal elements are extendedradially outward. The proximal elements may then be released byretracting the shaft. Release of the proximal elements allows them toextend radially outward and downward to contact the valve leaflet. Inthis arrangement, the valve leaflets are held between the proximal andthe distal elements. To assist in holding the leaflets the proximaland/or distal elements may included various friction accessories, suchas prongs or windings around the elements such as bands or barbs.Alternatively or in addition, the proximal elements and distal elementsmay interlock to prevent relative motion between the elements and moresecurely hold the leaflets.

In some embodiments, the proximal and distal elements are formed from acontinuous structure. The continuous structure may be held in a lowprofile position under tension. When the continuous structure isreleased and allowed to relax, the reforming of the structure allows thestructure to protrude outward at various points along the structure.Each protrusion is similar to an above-described proximal or distalelement and functions in a similar manner.

In a fifth aspect of the devices of the present invention, theinterventional catheter may include a fixation tool or device. In oneembodiment, the capture device may function as a fixation device whenleft in place. To this end, the capture device may be detachable and beleft behind as a permanent or temporary implant. Detachment may beachieved by a variety of different mechanisms and design features.

In other embodiments, the fixation tools are used with the capturedevice either incorporated into the interventional tool or used incombination with the interventional tool. In many of these embodiments,the fixation tools are advanceable through guide conduits disposed nearthe distal end of the interventional tool. The guide conduits are usedto guide the fixation tools to specific locations on the surfaces of theleaflets. The guide conduits are located proximal to the distal elementsand are capable of extending and retracting axially and angularlyoutward from the shaft. Any angle may be used to target the leaflets atpoints which are approximately one to twelve millimeters inward or awayfrom the free edge of each leaflet. Typically, the guide conduit is usedto introduce a fixation tool comprising a penetrating device or needle.The needle may house a suture having an anchor disposed at the distalend of the suture. The needle is advanced toward a valve leaflet topenetrate the leaflet and emerge from the other side. The anchor may bedeployed on the opposite side of the leaflet by passing the anchorthrough the needle and expanding or allowing it to self-expand after ithas exited the needle. Alternatively, the anchor may be mounted on theoutside of the needle and covered by a sheath. Retraction or removal ofthe sheath would allow expansion of the anchor. In any case, afteranchor deployment, the needle is then retracted while maintaining theanchor on the distal side of the leaflet. A number of different types ofanchors may be used during fixation of the leaflets. Typically theanchor is expandable from a compressed, low profile state, for deliveryto the anchoring site, to an expanded state to provide a large enoughsurface for anchoring support. In addition, the fixation tools mayinclude snares which are deployable on the distal side of the leafletfor capturing at least part of an anchor. The snare may then beretracted to move the anchor, such as to draw the anchor through apenetration in the leaflet. Once the suture is placed through theleaflets, either attached to anchors or free from anchors, the sutureends or lines may then be fixed together by conventional knot tying orany suitable method, including positioning suture fasteners.

The methods, devices and systems of the present invention may beprovided in one or more kits for such use. The kits may include aninterventional catheter configured to pass from the remote vasculatureof a patient to a position within the heart adjacent to a cardiac valveto be repaired, wherein the catheter has a capture device comprising atleast one distal element, and instructions for use. The instructions foruse may set forth any of the methods of the present invention.Optionally, such kits may further include any of the other systemscomponents described in relation to the present invention and any othermaterials or items relevant to the present invention.

Other objects and advantages of the present invention will becomeapparent from the detailed description to follow, together with theaccompanying drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a schematic illustration of the left ventricle of a heartshowing blood flow during systole with arrows.

FIG. 2A shows normal closure of the leaflets, while FIG. 2B showsabnormal closure of the leaflets.

FIG. 3 is a perspective side view of the mitral valve showing aninterventional tool approaching the valve leaflets from the atrial side.

FIG. 4 illustrates a short axis view if the mitral valve from the atrialside wherein elements of the interventional tool are shown in dashedoutline as they are positioned on the ventricular side of the valve.

FIG. 5 illustrates the mitral valve as in FIG. 4 during diastole.

FIG. 5A illustrates the valve leaflets fixed together as in a surgicalbow tie repair.

FIGS. 6-7 show exemplary antegrade approaches to the mitral valve fromthe venous vasculature.

FIGS. 8-9 show exemplary retrograde approaches to the mitral valvethrough the aortic valve and atrial vasculature.

FIGS. 10A-10C show a number of embodiments of capture devices which maybe disposed at the distal end of an interventional catheter.

FIGS. 11A-11C and FIG. 12 show a number of embodiments of capturedevices wherein an element is in the form of a block, rod, or bar.

FIG. 13 illustrates the extension of a first element independently of asecond element.

FIG. 14 illustrates elements having differing angles of curvature.

FIG. 15 illustrates a capture device having extended elements pinchedbetween the shaft and the cap.

FIGS. 16A-16E illustrate an embodiment of the capture device wherein thedistal elements are held in a retracted position under tension and areextendible upon release.

FIGS. 16F-16G illustrate an embodiment of the capture device wherein thedistal elements extend and retract together.

FIGS. 17A-17D show a number of embodiments of the interventional toolcomprising proximal elements which are capable of protruding outwardfrom the shaft at a location proximal to the distal elements.

FIGS. 18A-18D show embodiments of the capture device wherein the valveleaflets are pinched between a superior loop and an inferior loop.

FIGS. 19A-19B are perspective views of a capture device wherein theproximal elements and the distal elements are interlockable, and FIG.19C illustrates a top view showing the interlocked elements.

FIGS. 20A-20B illustrate an embodiment of the capture device wherein theproximal and distal elements are formed by a continuous structure.

FIG. 21A illustrates leaflets captured by a capture device detached fromthe shaft and left behind as a fixation device.

FIGS. 21B-21H illustrates a variety of embodiments of detachmentmechanisms.

FIGS. 2H-21J illustrate the use of capture devices having a pledget foruse as a fixation device.

FIG. 22 illustrates an embodiment of the interventional tool havingdistal elements and guide conduits disposed near its distal end.

FIGS. 23A-23B illustrates the placement of a suture having an anchorwith the use of a penetrating device advanced through a guide conduit.

FIGS. 24, 25, 26A-26B, 27A-27N, 27P-27R, and 27T illustrate variousembodiments of anchors. FIGS. 27O and 27S not used.

FIGS. 27U-27V illustrate anchors deployed from a doubled barreleddelivery device.

FIGS. 28 depicts a perspective view of an embodiment of theinterventional tool having more than one guide conduit.

FIG. 29 depicts a top view of the interventional tool of FIG. 28positioned between the valve leaflets.

FIG. 30 illustrates target points through which sutures may be placedand drawn together in the direction of the arrows.

FIG. 31 illustrates an anchor placed through a target point and a snareplaced through an adjacent target point, wherein the snare captures theanchor.

FIG. 32 illustrates sutures placed by the method illustrated in FIG. 31,wherein the sutures are fastened together to repair the valve.

FIG. 33 illustrates the method of FIG. 31 performed on two adjacentvalve leaflets.

FIG. 34 illustrates an embodiment of the interventional tool having morethan one guide conduit including at least two slotted needles for use indeploying a suture line.

FIG. 35 illustrates a continuous suture line placed according to themethods illustrated in FIG. 34.

FIG. 36 illustrates an embodiment of the interventional tool having aguide conduit wherein a penetrating device is advanced through the guideconduit having a suture holding feature disposed near its distal end.

FIG. 37 illustrates a distal element of a capture device comprising aloop having a second loop comprised of suture.

FIG. 38 shows a cross-sectional view of the element shown in FIG. 37.

FIGS. 39-41 illustrate methods of using the interventional toolillustrated in FIGS. 36-38.

FIGS. 42-51 illustrate a first device embodiment and methods of useaccording to the aspects of the present invention.

FIG. 52-58 illustrate a second device embodiment and methods of useaccording to the aspects of the present invention.

FIG. 59 illustrates a kit constructed in accordance with the principlesof the present invention.

DETAILED DESCRIPTION OF THE INVENTION

I. CARDIAC PHYSIOLOGY. The left ventricle LV of a normal heart H insystole is illustrated in FIG. 1. The left ventricle LV is contractingand blood flows outwardly through the tricuspid (aortic) valve AV in thedirection of the arrows. Back flow of blood or “regurgitation” throughthe mitral valve MV is prevented since the mitral valve is configured asa “check valve” which prevents back flow when pressure in the leftventricle is higher than that in the left atrium LA. The mitral valve MVcomprises a pair of leaflets having free edges FE which meet evenly toclose, as illustrated in FIG. 1. The opposite ends of the leaflets LFare attached to the surrounding heart structure along an annular regionreferred to as the annulus AN. The free edges FE of the leaflets LF aresecured to the lower portions of the left ventricle LV through chordaetendineae CT (referred to hereinafter as the chordae) which includeplurality of branching tendons secured over the lower surfaces of eachof the valve leaflets LF. The chordae CT in turn, are attached to thepapillary muscles PM which extend upwardly from the lower portions ofthe left ventricle and interventricular septum IVS.

A number of structural defects in the heart can cause mitral valveregurgitation. Regurgitation occurs when the valve leaflets do not closeproperly allowing leakage from the ventricle into the atrium. As shownin FIG. 2A, the free edges of the anterior and posterior leafletsnormally meet along a line of coaptation C. An example of a defectcausing regurgitation is shown in FIG. 2B. Here an enlargement of theheart causes the mitral annulus to become enlarged, making it impossiblefor the free edges FE to meet during systole. This results in a gap Gwhich allows blood to leak through the valve during ventricular systole.Ruptured chordae can also cause a valve leaflet to prolapse sinceinadequate tension is transmitted to the leaflet via the chordae. Whilethe other leaflet maintains a normal profile, the two valve leaflets donot properly meet and leakage from the left ventricle into the leftatrium will occur. Such regurgitation can also occur in patients whohave suffered ischemic heart disease where papillary muscles do notcontract sufficiently to effect proper closure.

II. GENERAL OVERVIEW. The present invention provides methods and devicesfor grasping, and optional repositioning and fixation of the valveleaflets to treat cardiac valve regurgitation, particularly mitral valveregurgitation. Such grasping will typically be atraumatic providing anumber of benefits. For example, atraumatic grasping may allowrepositioning of the devices relative to the leaflets and repositioningof the leaflets themselves without damage to the leaflets. However, insome cases it may be necessary or desired to include grasping whichpierces or otherwise permanently affects the leaflets. In some of thesecases, the grasping step includes fixation. Although a number ofembodiments are provided to achieve these results, a general overview ofthe basic features will be presented herein. Such features are notintended to limit the scope of the invention and are presented with theaim of providing a basis for descriptions of individual embodimentspresented later in the application.

Generally, the valve leaflets are grasped and repositioned by pressing acapture device against the ventricular surface of the leaflets. Theventricular surface is the generally planar surface of the valve thatfaces the ventricle. Access to the ventricular surface will be describedin the following section, however it is basically assumed that theventricular surface is accessible by a retrograde approach through theventricle or by an antegrade approach through the atrium and thenpassing through the valve to the ventricle. For illustration purposes,an antegrade approach will be described.

Referring to FIG. 3, a interventional tool 100, having a shaft 104 and acapture device 105 comprising two elements 106 protruding radiallyoutward from the distal end 102 of the shaft 104, is shown approachingthe mitral valve MV from the atrial side. The mitral valve MV is shownin a perspective side view wherein the valve leaflets LF open throughthe valve annulus AN during diastole. In such a position, the chordae CTare can be seen attached along the free edge FE of the leaflet LF andthe ventricular surface VS is visible. Short-axis echocardiography maybe used to visualize the interventional tool 100 and orient the elements106 so that they are positioned substantially perpendicular to the lineof coaptation C. The tool 100 may be moved roughly along the line ofcoaptation to the location of regurgitation. Under long-axis echoguidance, the elements 106 are then advanced through the valve, betweenthe leaflets LF in the direction of the arrow 108, so that the elements106 emerge beyond the valve. In this perpendicular position, the tool100 is then retracted, pressing the elements 106 against the ventricularsurface of the leaflets LF. This grasps the leaflets LF and pulls theleaflets up close to the annular plane so that the grasped free edgesare coapted. This is illustrated in FIG. 4, a short-axis view of themitral valve MV from the atrial side. Here the elements 106 are shown indashed outline as the elements 106 are positioned on the ventricularside of the valve.

The interventional tool 100 is dimensioned at its waist 110 to fitbetween adjacent chordae where the chordae attach to the free edge. Theelements 106 may be dimensioned to have a width 112 which is greaterthan the distance between the adjacent chordae, effectively trapping thechordae, however this is not necessary. In addition, the opposingtensioning force of the chordae on the free edge FE of the leafletshelps secure the leaflets LF on the elements 106. Such dimensioning andpositioning prevents displacement of the leaflets LF from theinterventional tool 100 due to the diastolic pressure gradient on theleaflets LF and relative movement of the annulus to the elements 106.This is shown in FIG. 5, a short-axis view of the mitral valve MV fromthe atrial side during diastole wherein the leaflets LF remain inposition against the elements 106 surrounded by openings 114 whichresult from the diastolic pressure gradient. This simulates the doubleorifice geometry of a standard surgical bow-tie repair. Color Dopplerecho will show if the regurgitation of the valve has been reduced. Ifthe resulting mitral flow pattern is satisfactory, the leaflets may befixed together in this orientation with a suture 115 or fixation device,as shown in FIG. 5A. If the resulting color Doppler image showsinsufficient improvement in mitral regurgitation, the interventionaltool 100 may be repositioned. This may be repeated until an optimalresult is produced wherein the leaflets LF may then be fixed.

As will be discussed later, the interventional tool 100 may take anumber of forms and may be comprised of a variety of materials, eachdesign choice providing variations to the above described methods anddevices. Further, the tool 100 may include provisions for fixing theleaflets together after repositioning. Thus, the above provideddescription simply sets forth a sampling of basic features of thepresent invention.

III. ACCESS TO THE MITRAL VALVE. Access to the mitral valve or othercardiac valve will preferably be accomplished through the patient'svasculature in a “percutaneous” manner. By “percutaneous” it is meantthat a location of the vasculature remote from the heart is accessedthrough the skin, such as using needle access through, for example, theSeldinger technique. However, it may also include using a surgical cutdown procedure or a minimally invasive procedure. The ability topercutaneously access the remote vasculature is well-known and describedin the patent and medical literature. Depending on the point of vascularaccess, the approach to the mitral valve may be antegrade and requireentry into the left atrium via the pulmonary vein or by crossing theinteratrial septum. Alternatively, approach to the mitral valve can beretrograde where the left ventricle is entered through the aortic valve.Once percutaneous access is achieved, the interventional tools andsupporting catheter(s) will be advanced to the heart intravascularlywhere they may be positioned adjacent the target cardiac valve in avariety of manners, as described elsewhere herein. While the methodswill preferably be percutaneous and intravascular, many of the tools andcatheters described herein will, of course, also be useful forperforming open surgical techniques where the heart is beating orstopped and the heart valve accessed through the myocardial tissue. Manyof the devices will also find use in minimally invasive procedures whereaccess is achieved thorascopically and where the heart will usually bestopped but in some instances could remain beating.

A typical antegrade approach to the mitral valve is depicted in FIG. 6.The mitral valve MV may be accessed by a standard approach from theinferior vena cava IVC or superior vena cava SVC, through the rightatrium RA, across the interatrial septum IAS and into the left atrium LAabove the mitral valve MV. As shown, a catheter 120 having a needle 122may be advanced from the inferior vena cava IVC into the right atriumRA. Once the catheter 120 reaches the interatrial septum IAS, the needle122 may be advanced so that it penetrates through the septum at thefossa ovalis FO or the foramen ovale into the left atrium LA. At thispoint, a guidewire may be advanced out of the needle 122 and thecatheter 120 withdrawn. As shown in FIG. 7, access through theinteratrial septum IAS will usually be maintained by the placement of aguide catheter 125, typically over a guidewire 124 which has been placedas described above. The guide catheter 125 affords subsequent access topermit introduction of the tool(s) which will be used for performing thevalve or tissue modification, as described in more detail below.

A typical retrograde approach to the mitral valve is depicted in FIG. 8.Here the mitral valve MV may be accessed by an approach from the aorticarch AA, across the aortic valve AV, and into the left ventricle belowthe mitral valve MV. The aortic arch AA may be accessed through aconventional femoral artery access route, as well as through more directapproaches via the brachial artery, axillary artery, or a radial orcarotid artery. As shown in FIG. 9, such access may be achieved with theuse of a guidewire 128. Once in place, a guide catheter 126 may betracked over the guidewire 128. The guide catheter 126 affordssubsequent access to permit introduction of the tool(s) which will beused for performing the valve modification, as described in more detailbelow.

In some cases, access routes to the mitral valve may be established inboth antegrade and retrograde approach directions. This may be usefulwhen, for instance, grasping is performed with the use of specificdevices introduced through one route and fixation is achieved with theuse of separate devices introduced through another route. In onepossible situation, the leaflets may be grasped and repositioned bypressing a interventional tool against the ventricular surface of thevalve via a retrograde approach. While the interventional tool is inplace, a fixation tool may be introduced via an antegrade approach tofix the leaflets in place. Thus, a variety of access routes may be usedindividually or in combination with the methods and devices of thepresent invention.

IV. LEAFLET CAPTURE DEVICE. Once the valve is accessed and theguidecatheter is positioned in place, the interventional catheter isintroduced through the guidecatheter for use in capturing or holding thevalve leaflets. The interventional catheter typically comprises a shaft,having a proximal end and a distal end, and an interventional tooldisposed near its distal end. The interventional tool may take a numberof forms to perform the methods of the present invention. Fundamentally,the interventional tool comprises a capture device comprising at leastone distal element capable of protruding radially outward from theshaft. Typically, the tool will have two distal elements, one element topress upwardly against each leaflet of the two leaflet that are to befixed together. However, the tool may have any number of such elements,including multiple elements pressing against each of the leaflets or oneelement pressing against one leaflet and no element pressing against anadjacent leaflet. Any of these combinations may effectively coapt a pairof leaflets. Further, multiple elements may be present to reposition andcoapt three leaflets, such as for use with the aortic valve.

FIGS. 10A-10C show a number of embodiments of capture devices 204 thatmay be disposed at the distal end 202 of an interventional catheter 200.As described, each device 204 will typically have two distal elements208 which are protrudable radially outward from the shaft 210. In manyembodiments, the elements 208 extend from opposite sides of the shaft210 so the elements 208 are approximately 180 degrees apart. However, itmay be appreciated that the elements 208 may be spaced any distanceapart and may be symmetrically or asymmetrically arranged.

In addition, the distal elements 208 may take a number of forms,including bars, rods, flaps, sheets, blocks or loops to name a few.These forms can in turn take a number of shapes, such as rectangular,circular, oblong, elliptical and petal. Further, these forms may becomprised of a number of materials, including wire, ribbon, filaments orfibers which are made from stainless steel, metals, nitinol,shape-memory alloy, polymers, silk, polyester or nylon, to name a few.Such materials may also be radiopaque to aid in visualization. Likewise,the elements may be comprised of a combination of such forms and/ormaterials. As an example, FIG. 10A illustrates elements 208 in the formof loops 212 having a petal shape. Here, the loops are positioned onopposite sides of the shaft 210 so as to form a “figure-8” shape in atop view or a bottom view. These loops 212 are preferably made fromnitinol or shape-memory wire, however other materials may be suitable.The loops 212 may protrude from the shaft 210 by a means of a number ofdesigns. For example, as illustrated in FIG. 10A, the loops may protrudefrom a space between the shaft 210 and a cap 238 located at its tip.Alternatively, the loops 212 may protrude through the shaft 210, asshown in FIG. 10B, or through the cap 238. This may lend support to theloops 212 during use. As will be discussed later, such loops 212 may becombined with a second set of loops comprised of suture that aredetachable from these loops 212 for leaflet fixation. FIG. 10Cillustrates elements 208 in the form of flaps or sheets 214 which areessentially rectangular such as made from ribbon or other flatmaterials. These sheet 214 are also preferably made from nitinol orshape-memory wire, however other materials may be suitable.

FIG. 11A illustrates a element 208 in the form of a block, rod or bar216 disposed perpendicularly to the shaft 210. The bar 216 may becomprised of any number of materials, including metals, alloys, polymersor fibers, to name a few. When such a bar 216 forms one continuouselement 208 which extends beyond the diameter of the shaft, as shown,the bar 216 may pivot (indicated by arrows) around a pivot point 218 atthe base of the shaft 210 to manipulate the position of the bar 216. Asshown in FIG. 11B, the bar 216 may further comprise a pull-wire 219which extends from the shaft 210 to the bar 216 and loops through thebar 216 to connect with each end of the bar 216. By retracting orpulling upwards on the pull-wire 219 the bar 216 will pivot around apivot point 218 at the base of the shaft 210. This orients the bar 216to a low profile position so that the interventional tool may moreeasily be passed through a guidecatheter and further between a set ofvalve leaflets LF, as shown. Once the element 208 is advanced anddisposed below the valve, as shown in FIG. 11C, the element 208 is thenpressed against the ventricular surface 217 of the leaflets LF to graspand reposition the leaflets. Since the bar 216 is pivotable around acenter pivot point 218, the bar 216 may slightly pivot during graspingbased on the anatomy of the valve. This may allow a more desirableapplication of force to the valve leaflets, as a less rigid leaflet mayreceive a larger force to draw the leaflet up to a coapted position. Ina similar design, each element 208 may pivot independently of the otheraround a pivot point at the base of the shaft. This is possible whensuch a bar or rod forms two elements 208 extending 180 degrees apartoutwardly from the shaft 210. This may provide an even higher degree offlexibility during grasping.

Referring to FIG. 12, the element 208 may be comprised of a combinationof forms and materials. Here, the element has the form of a block 220having cutouts 222 surrounded by wire loops 224. Such loops 224 mayincrease the area in which the element 208 may contact the leaflet LF.In addition, such loops 224 may be adjustable to aid in manipulation andrepositioning of the leaflets. Further, the block 220 may be pivotablearound a center pivot point 218 at the base of the shaft 210 tomanipulate the position of the block 220 as in the manner described andshown in FIGS. 11B-11C.

In many embodiments, the distal elements are individually extendable,retractable and repositionable. FIG. 13 illustrates the extension of afirst element 230 independently of the second element 232. Such elements230, 232 may be utilized in this arrangement or the second element 232may be extended at any point during the procedure. Likewise, theelements 230, 232 may be extended or retracted by variable amounts forprotrusion of various distances from the shaft 210. Such extension andretraction may also adjust the width 231 of the exposed elements 230,232 if the width of the element 230, 232 varies radially from the shaft,such as with a petal shape. In addition, the elements 230, 232 may beindividually rotatable around the shaft 210 to vary the distance betweenthe elements 230, 232. Further, as shown in FIG. 14, the elements 230,232 may have differing angles of curvature. Here, the first element 230has a first radius of curvature 234 which is larger than a second radiusof curvature 236 of the second element 232. This may be achieved by heatshaping the elements 230, 232 to have different curvatures, or thecurvatures may be adjusted by manipulation by the user at the proximalend of the interventional catheter 200. Consequently, each element 230,232 will provide a different repositioning effect when pressed against aleaflet.

In some embodiments, the capture device 204 has a cap 238 located at itstip. Such a cap 238 has been shown in embodiments presented in FIGS.10A, 10C, 13, and 14 and may provide a variety of functions. Forexample, the cap 238 may serve as a blunt tip to assist in atraumaticpassing of the device 204 through the valve, between valve leaflets,during placement of the device 204. The cap 238 may also be moveable toclose a gap 240 between the cap 238 and the shaft 210 where the distalelements 230, 232 emerge. When the elements 230, 232 are retracted,movement of the cap 238 to close the gap minimizes the profile of thetool 204 and reduces the possibility of the elements 230, 232 orportions of the device 204 interfering with tissue or entangling withchordae. As shown in FIG. 15, when the elements 230, 232 are extended,movement of the cap 238 to close the gap 240 may increase rigidity ofthe elements 230, 232 by providing support for the elements 230, 232 orit may adjust the curvature of the elements 230, 232 by flexing aportion of the elements 230, 232 near the shaft 210. Further, when theelements 230, 232 are pressed against the ventricular surface of thevalve leaflets, the leaflets may extend into the gap 240 between the cap238 and the shaft 210. When the cap 238 is moved to close the gap 240,the leaflets may be pinched between the shaft 210 and the elements 230,232 and cap 238. This may assist grasping of the leaflets for laterfixation. It may be appreciated that although these elements have beenillustrated as curving upwardly, away from the distal end, the elementsmay alternatively be uncurved, curve downwardly, include compoundcurvatures or more than one curvature along each element, or any othercombination of curvatures.

In some embodiments, the distal elements are held in a retractedposition under tension and are extendable upon release. For example,FIGS. 16A-16C illustrate one embodiment of the interventional tool 204in various states of deployment. The elements 230, 232 are disposed neara distal end 231 of an inner shaft 233 within the shaft 210. FIG. 16Ashows the elements 230, 232 in a retracted position as they are heldunder tension by loops 221, each loop 221 threaded through an element230, 232 and pulled upwardly within the shaft 210 as shown. The loops221 may be comprised of any suitable material, including suture, wire orpolymer strands. It may be appreciated that the tool 204 may beintroduced in this state or the inner shaft 233 and elements 230, 232may be retracted within the shaft 210 and later deployed to this statewhen near the valve. FIG. 16B shows the elements 230, 232 in an extendedstate of deployment. Here, the upward force on the loops 221 have beenrelaxed and the tension released. Consequently, the elements 230, 232extend outwardly as shown and the relaxed loops 221 hang at anylocation. As shown in FIG. 16C, the loops 221 may then be slid to towardthe inner shaft 233 so that the elements 230, 232 may more easily engagethe valve leaflets LF.

FIGS. 16D-16E illustrate another embodiment wherein the distal elementsare held in a retracted position under tension and are extendable uponrelease. Here, the elements 230, 232 are disposed near the distal endthe shaft 210. FIG. 16D shows the elements 230, 232 in a retractedposition as they are held downward against the shaft 210 under tensionby loops 221, each loop 221 threaded through an element 230, 232 andpulled upwardly within the shaft 210 as shown. The loops 221 may becomprised of any suitable material, including suture, wire or polymerstrands. FIG. 16E shows the elements 230, 232 in an extended state ofdeployment. Here, the upward force on the loops 221 have been relaxedand the tension released. Consequently, the elements 230, 232 extendupwardly and outwardly as shown and the relaxed loops 221 are drawnupward to hang from the extended elements 230, 232.

In some embodiments, the distal elements extend and retract together, anexample of which is illustrated in FIGS. 16F-16G. Referring to FIG. 16A,the elements 230, 232 are disposed at the distal end 231 of the innershaft 233 within the shaft 210. The elements 230, 232 pass through theshaft 210 wall and outside the shaft 210 at locations 235, 237 desiredfor element protrusion. Upon retracting the inner shaft 233, as shown inFIG. 16B, the elements 230, 232 together are guided radially outwardthrough the shaft 210 at the locations 235, 237. It may be appreciatedthat although the elements 230, 232 in FIGS. 16A-16G have beenillustrated as curving downwardly, towards the distal end, the elementsmay alternatively be uncurved, curve upwardly, include compoundcurvatures or more than one curvature along each element, or any othercombination of curvatures.

In a number of embodiments, an example of which is shown in FIGS.17A-17D, the interventional tool 204 also comprises proximal elements240, 242 which are capable of protruding radially outward from the shaftat a location which is proximal to the elements 230, 232 previouslydescribed. The proximal elements 240, 242 may have any of the forms,shapes, material compositions, features, or capabilities described inrelation to the distal elements 230, 232. In FIG. 17A, such proximalelements 240, 242 are shown as loops. Such proximal elements 240, 242would most commonly be used in embodiments of capture devices 204designed for an antegrade approach to the valve wherein the device 204crosses the valve to access the ventricular surface of the leaflets.Typically, once the distal elements 230, 232 are extended and positionedagainst the ventricular surface of the leaflets, the proximal elements240, 242 are then extended and positioned against the artrial surface ofthe leaflets. As shown in FIG. 17B, the leaflets LF are thus securedbetween the proximal elements 240, 242 and distal elements 230, 232. Theproximal elements 240, 242 and/or distal elements 230, 232 may then beextended, retracted or similarly adjusted to further orient theleaflets. In addition, the cap 238 may optionally be retracted towardthe shaft 210 to further pinch the leaflets between the elements.

Referring to FIG. 17C, the proximal elements 240, 242 may be separatelydeployable from the distal elements 230, 232. Here, the elements 240,242, 230, 232 are disposed near the distal end 231 of the inner shaft233 within shaft 210. The proximal elements 240, 242 are constrainedwithin the shaft 210 while the distal elements 230, 232 are extendedradially outward. In this state, the distal elements 230, 232 may bepositioned against the ventricular surface of the valve leaflets LF. Theproximal elements 240, 242 may then be released by retracting the shaft210. As shown in FIG. 17D, release of the proximal elements 240, 242allows them to extend radially outward and downward, as illustrated byarrows. Depending on the curvature of the proximal elements 240, 242,they may remain proximal to, move to within the same plane of, or movebeyond the plane of the distal elements 230, 232. In addition, theproximal elements may include various friction accessories 227, such asprongs, to assist in holding the valve leaflets LF. Other frictionaccessories 227 include windings around the elements, such as metal,polymer or suture windings, cuffs, bands, or barbs. Further, suchaccessories 227 may additionally or alternatively be included on thedistal elements 230, 232. Likewise, such accessories 227 may be includedon the elements of the capture devices in any of the embodiments of theinterventional tool. In an additional embodiment, depicted in FIGS.18A-18D, the valve leaflets LF may be pinched between a proximal elementor superior loop 720 and a distal element or inferior loop 721. In apreferred embodiment, the capture device or grasper is comprised of anitinol flat ribbon heat set in the shape of double loops 720, 721. Theribbon may be mounted on a series of three coaxial shafts, an interiorshaft 725, a central shaft 726 and an exterior shaft 727. The distal endof the ribbon may be attached to the distal end 730 of the interiorshaft 725, a midportion of the ribbon may be attached to the distal end731 of the central shaft 726, and the proximal end of the ribbon may beattached to the distal end 732 of the exterior shaft 727. One or moreribbons may be mounted on the coaxial shafts; in this example, tworibbons are shown 180 degrees apart. When extended, as shown in FIG.18A, the grasper may be pulled flat against the shafts 725, 726 ,727 forease of insertion through a guide catheter or tool and into a desiredposition between the valve leaflets LF. When the central shaft 726 isretracted or the exterior shaft 727 advanced, as shown in FIG. 18B, thesuperior loops 720 may extend radially from the shafts. The superiorloops 720 may rest on the superior surface of the valve leaflets LF inthe atrium, as shown in FIG. 18D. In this position, the superior loops720 may aid in orientation assessment, as the superior loops may be echoor fluorogenic and may be easily visible in relation to the cardiacstructures or other devices or components. When positioned in a desiredlocation, the interior shaft 725 may then be retracted, as shown in FIG.18C, to extend the inferior loops 721 radially from the shafts. Theinferior loops 721 may be in contact with the inferior surface of thevalve leaflets LF in the ventricle. Thus, the valve leaflets LF may bepinched between the inferior loop 721 and superior loop 720. It may alsobe appreciated that the inferior loops 721 may be deployed prior to thesuperior loops 720.

Further, the proximal elements 240, 242 and distal elements 230, 232 mayinterlock to prevent relative motion between the elements and moresecurely hold the leaflets LF. Referring to FIG. 19A, a distal element230 is shown protruding radially outwardly from the shaft 210. In thisexample, the distal element 230 is shaped having a raised upwardlypointing tip portion 243 and two side portions 245. The proximal element240 is shown protruding radially outwardly from the shaft 210 at alocation proximal to the distal element 230. Here, the proximal element240 is shaped having two downwardly pointing tip portions 247, 249. Whenthe elements 230, 240 are drawn together, as shown in FIG. 19B, theraised upwardly pointing tip portion 243 fits between the two downwardlypointing tip portions 247, 249 locking the elements 230, 240 together.This may be more easily visualized in a top view of the interlockedelements 230, 240 shown in FIG. 19C. It may be appreciated that, in use,the distal element 230 is extended and positioned against a ventricularsurface of a leaflet, the proximal element 240 is extended andpositioned against an artrial surface of the leaflet. Thus, the leafletis thus secured between the elements 230, 240 in the interlockedorientation.

In some embodiments, the proximal and distal elements are formed by acontinuous structure. Referring to FIG. 20A, the continuous structure260 is shown in a low profile position wrapped around the end portion262 of the shaft 210 of the interventional catheter 200 under tension.In this profile position, the catheter 202 is advanced with an atrialapproach through the valve, between the leaflets LF, so that the distalend 202 extends beyond the valve into the ventricle. Referring to FIG.20B, the continuous structure 260 is then released and allowed to relax.Prior heat forming allows the structure 260 protrude radially outward atvarious points along the structure 260. Each protrusion is similar to anabove described proximal or distal element and functions in a similarmanner. The embodiment shown in FIGS. 20A-20B includes protrusionssimilar to both proximal elements 240, 242 and distal elements 230, 232as shown. These elements may protrude various distances and at variousangles from the shaft, as previously described.

Many features of the distal elements 230, 232 and proximal elements 240,242 have been described and illustrated with embodiments comprising wireloops. It may be appreciated that the described features are applicableto any of the above described embodiments, such as blocks, rods,ribbons, etc. Use of wire loops as examples are not intended to limitthe scope of the present invention.

IV. LEAFLET FIXATION TOOL. With the valve leaflets grasped in a desiredorientation using an embodiment of the capture device described above,the leaflets may be fixed together to maintain this orientation. Thismay be achieved by leaving the capture device in place to function as afixation device. To this end, the capture device may be detachable fromthe interventional tool to be left behind as a permanent or temporaryimplant. FIG. 21A illustrates a capture device comprising distalelements 230, 232 and proximal elements 240, 242 wherein the leaflets LFare captured therebetween. As shown, the capture device may be detachedfrom the shaft 210 and left behind as a fixation device. Detachment maybe achieved by a variety of different mechanism and design features.FIGS. 21B-21H illustrate embodiments of such detachment mechanisms. FIG.21B shows an upper shaft 312 and a detachable lower shaft 313 which areinterlocked at a joining line 314. The joining line 314 may have anyshape or curvature which will allow or facilitate interlocking and laterdetachment. A snuggly fitting outer sheath 315 is positioned over theshafts 312, 313 to cover the joining line 314 as shown. FIG. 21Cillustrates detachment of the lower shaft 313 from the upper shaft 312.This is achieved by retracting the outer sheath 315, so that the joiningline 314 is exposed, which allows the shafts 312, 313 to separate.Similarly, FIG. 21D illustrates a tubular upper shaft 316 and adetachable tubular lower shaft 317 which are interlocked at a joiningline 314. Again, the joining line 314 may have any shape or curvaturewhich will allow or facilitate interlocking and later detachment. Asnuggly fitting rod 318 is inserted through the tubular shafts 316, 317to bridge the joining line 314 as shown. FIG. 21E illustrates detachmentof the lower shaft 317 from the upper shaft 316. This is achieved byretracting the rod 318 to a position above the joining line 314 which inturn allows the shafts 316, 317 to separate.

FIGS. 21F-21H illustrate another embodiment of a detachment mechanism.

Referring to FIG. 21F, an upper shaft 900 is shown attached to adetachable lower shaft 902. An outer tube 910 surrounds the upper shaft900 and contacts the lower shaft 902 as shown. The upper shaft 900 isheld in attachment to the lower shaft 902 by the presence of a ball 904or similar device which is disposed in recess 906, shaped to receive aportion of the ball 904, in the lower shaft 902. The ball 904 is held inthe recess 906 by an angular cutout 908 in the upper shaft 900.Referring to FIG. 21G, the upper shaft 900 may be retracted. This may beachieved by pulling the upper shaft 900 upwards within the outer tube910 while the outer tube 910 applies force on the lower shaft 902 to aidseparation. As the upper shaft 900 is retracted, the angular cutout 908allows the ball 904 to move from the recess 906 to a position within theupper shaft 900. Referring to FIG. 21H, upper shaft 900 and ball 904 mayretracted into the outer tube 910, completing the detachment from thelower shaft 902. It may be appreciated that this detachment mechanismconcept may be used with other shaped shafts, recesses, and balls orsimilar devices and may function without the use of the outer tube.

In some cases, use of the capture device as a fixation device may createone or more small gaps between the leaflets LF at the coaptation line.If this is likely to occur, or as an added precaution, a block, disk orpledget 321 of material may be positioned such that it blocks possibleflow through such a gap. As shown in FIG. 21I, the pledget 321 may bepositioned between the proximal elements 240, 242 and distal elements230, 232. When the leaflets LF are captured between the proximalelements 240, 242 and distal elements 230, 232, as shown in a top viewin FIG. 21J, the pledget 321 is positioned between the leaflet LF edgesto block flow therethrough.

Alternatively, fixation may be accomplished with the use of separatedevices used in combination with an interventional tool having a capturedevice. And, many embodiments of the present invention incorporate afixation tool into the interventional tool for such use. The fixationtools described herein below may be used with any of the capture devicespreviously described. A few examples will be presented to illustratepossible embodiments.

In many embodiments, such as illustrated in FIG. 22, the interventionaltool 100 has distal elements 302 and guide conduits 304 disposed nearits distal end 306. Guide conduits 304 such as these may be used toguide a number of tools or devices to specific locations near the distalend 306. For example, in this case, the guide conduits 304 are used toguide fixation tools to specific locations on the surfaces of theleaflets. In addition, as will be described in a later section, theconduits 304 may be attached to the proximal loops. In addition to otherbenefits described later, the conduits 304 may provide added support orrigidity to the interventional tool which may aid in the fixationprocess.

As shown in FIG. 22, the guide conduits 304 are located proximal to thedistal elements 302 and are capable of extending angularly outward fromthe shaft 308. It may be appreciated that the conduits 304 may belocated at any point along the shaft 308 and may be capable of extendingat any angle 310. Typically, such an angle 310 ranges from approximately90 degrees, perpendicular to the shaft, to around zero degrees,essentially parallel to the shaft. Any angle 310 may be used to targetthe leaflets LF at points which are approximately 1-12 mm, preferably3-5 mm, inward from the free edge FE of each leaflet LF. In a particularembodiment of the interventional tool 100, the guide conduit 304 is usedfor fixation. Here, the guide conduit 304 is used to introduce afixation tool 305 comprising a penetrating device or needle 320 housinga suture 322 having an anchor 324 disposed at the distal end of thesuture 322. The needle 320 is advanced toward a valve leaflet, either byextension of the guide conduit 304 or the needle 320 itself. In eithercase, the needle 320 is then advanced to penetrate the leaflet andemerge from the other side or the distal side of the leaflet . Theneedle 320 may be rigid, possibly made from a metallic material, orflexible, made from a flexible polymer, for example. As shown in FIG.23A, an atrial approach would involve the needle 320 penetrating theatrial surface 326 of the leaflet LF, passing through the leaflet LF andemerging on the ventricular surface 327 of the leaflet LF. Once emerged,the anchor 324 is deployed as shown. The anchor 324 may be deployed bypassing the anchor 324 through the needle 320 and expanding or allowingit to self-expand after it has exited the needle 320. Alternatively, theanchor 324 may be mounted on the outside of the needle 320 and coveredby a sheath. Retraction or removal of the sheath would allow expansionof the anchor 324. In any case, after anchor deployment, the needle 320is then retracted while maintaining the anchor 324 on the distal side ofthe leaflet LF. Consequently, the attached suture 322 remains in place,passing through the leaflet penetration. Once each fixation tool 305 hasdeployed its anchor 324 on the distal side of a leaflet LF, individuallyor simultaneously, the guide conduit 304 and interventional tool 204 areretracted. As shown in FIG. 23B, the ends of the sutures 322 may then befixed together by conventional knot tying or any suitable method,including positioning fasteners. This may be achieved with the use ofadditional tools which are part of the interventional catheter 200, orthis may be achieved by other methods after withdrawal and removal ofthe interventional catheter 200.

A number of different types of anchors 324 may be used during fixationof the leaflets. Typically, the anchor 324 is expandable from acompressed low profile state, for delivery to the anchoring site, to anexpanded state to provide a large enough surface for anchoring support.One embodiment of the anchor 324, shown in FIG. 24, is comprised of awire 360 curved into a ring shape. The wire 360 may be stainless steel,nitinol or other shape memory wire, polymer or similar material. Suture322 is attached to the center 366 of the ring by a bonding material. Thewire 360 has a first end 362 and a second end 364 wherein the first end362 is disposed on top of the ring and the second end 364 is disposedunderneath the ring as shown. This configuration provides support forthe ring when the anchor 324 is pulled snuggly against a valve leafletsurface by the suture 322. In addition, the first end 362 and second end364 may have radiopaque markers 365 disposed thereon. Referring to FIG.25, this embodiment of the anchor 324 is shown in possible use forfixation of valve leaflets. As described previously, an atrial approachwould involve the needle 320 penetrating the atrial surface 326 of theleaflet LF, passing through the leaflet LF and emerging on theventricular surface 327 of the leaflet LF. When the anchor wire 360 iscomprised of flexible materials, the anchor 324 is collapsible forloading within the needle 320. Once the needle 320 has emerged on theventricular surface 327, the anchor 324 is deployed as shown. The needle320 is then retracted while maintaining the anchor 324 on the distalside of the leaflet LF. Consequently, the attached suture 322 remains inplace, passing through the leaflet penetration. Once each fixation tool305 has deployed its anchor 324 on the distal side of a leaflet LF,individually or simultaneously, the guide conduit 304 and interventionaltool 204 are retracted. The sutures 322 may be pulled tight so that theanchors 324 are disposed against the leaflets LF and the ends of thesutures 322 may then be fixed together by conventional knot tying or anysuitable method, including positioning fasteners.

Another embodiment of the anchor 324, shown in FIGS. 26A-26B, involvestwo parts which are disposed on opposite sides of a valve leaflet.Referring to FIG. 26A, the anchor 324 is comprised of a first part 370and a second part 372 wherein the suture 322 is fixedly attached to thefirst part 370, slidably attached to the second part 372, and continuesto a free end 373 proximal to the second part 372. In addition, thefirst part 370 may have spikes 374 or other protrusions which interlockwith receptacles 376 in the second part 372. It may be appreciated thatsuch spikes 374 may be located on the second part 372 to interlock withreceptacles 376 on the first part 370 or such spikes 374 and receptacles376 may be located on both parts 370, 372. The anchor 324 may becomprised of flexible materials so that the anchor 324 is collapsiblefor loading within the needle 320. In this case, as previouslydescribed, the needle may penetrate the atrial surface 326 of theleaflet LF, pass through the leaflet LF and emerge on the ventricularsurface 327 of the leaflet LF. Here the first part 370 of the anchor 324is deployed, as shown in FIG. 26A. The needle 320 is then retractedwhile maintaining the first part 370 on the distal side of the leafletLF. Consequently, the attached suture 322 remains in place, passingthrough the leaflet. Once the needle 320 is disengaged from the leafletLF, the second part 372 of the anchor is deployed so the second part 372is disposed on the atrial surface 326 as shown. Referring to FIG. 26B,the parts 370, 372 may then be drawn together so the spikes 374 passthrough the leaflet LF and are received in the receptacles 376 lockingthe anchor in place. One or more sutures 322 with anchors 324 may beplaced in other locations on the same or other leaflets LF. The ends ofthe sutures 322 may then be fixed together by conventional knot tying orany suitable method, including positioning fasteners.

Another embodiment of the anchor 324, shown in FIGS. 27A-27B, involves asingle structure having flanges which are disposed on opposite sides ofa valve leaflet. Referring to FIG. 27A, the anchor 324 is comprised of astructure 381 having a first flange 380, a second flange 382 and acylindrical portion 383 therebetween. The suture 322 is fixedly attachedto the structure 381 as shown. In addition, the structure 381 mayoptionally include a compressible layer 384 on a surface of either thefirst flange 380, the second flange 382 or both facing the cylindricalportion 383. The anchor 324 may be comprised of flexible materials sothat the anchor 324 is collapsible for loading within the needle 320. Inthis case, as previously described, the needle may penetrate the atrialsurface 326 of the leaflet LF, pass through the leaflet LF and emerge onthe ventricular surface 327 of the leaflet LF. Here the structure 381 ispartially deployed so that the first flange 380 emerges and ispositionable against the ventricular surface 327. The needle 320 is thenretracted while maintaining the first flange 380 on the distal side ofthe leaflet LF. Consequently, cylindrical portion 383 emerges and ispositioned through the leaflet. As the needle 320 is disengages from theleaflet LF, the second flange 382 is deployed so the second flange 382is disposed on the atrial surface 326 as shown in FIG. 27B. One or moresutures 322 with anchors 324 may be placed in other locations on thesame or other leaflets LF. The ends of the sutures 322 may then be fixedtogether by conventional knot tying or any suitable method, includingpositioning fasteners.

Another embodiment of the anchor 324, shown in FIGS. 27C-27D, involves asingle tubular structure 800 having longitudinal slits 802 attached tothe end of the suture 322. As shown in FIG. 27C, the structure 800 maybe compressed to a low profile position so that it can be loaded withinor on the outside of a catheter, needle or other delivery device. Upondelivery, as shown in FIG. 27D, the structure 800 may expand so thatside-arms 804 project radially outward. This provides a broad surface torest against the leaflets. A similar embodiment, shown in FIGS. 27E-27F,comprises a tubular structure 810 having a central bar 812 to which thesuture 322 is attached. As shown in FIG. 27F, the structure 810 may becompressed to a low profile position. Upon delivery, as shown in FIG.27G, the structure 810 may expand so that side-arms 814 project radiallyoutward. Such positioning of the suture 322 may allow the anchor 324 tobe positioned more flush to the leaflets.

Another embodiment of the anchor 324, shown in FIGS. 27G-27H, involves atubular structure 820 attached to the end of the suture 322. As shown inFIG. 27G, the structure 820 may be mounted on the outside of a needle orintroductory device 822 in a low profile position. Upon delivery, asshown in FIG. 27H, the structure 820 may expand radially outward. Toachieve this, the structure 820 may be self expanding, wherein thestructure 820 is released by retracting a sheath or similar restrainingsupport. Or, the structure 820 may be mechanically expanded by action ofa balloon or similar device mounted on the introductory device. In anycase, introductory device 822 may then be removed.

Another embodiment of the anchor 324, shown in FIGS. 271-27J, involves alongitudinal structure 830 having a horizontal beam 832 attached to theend of the suture 322. As shown in FIG. 271, the structure 830 may becompressed to a low profile position so that it can be loaded within acatheter, needle or other delivery device. Upon delivery, as shown inFIG. 27J, the structure 830 may expand so that side-arms 834 projectradially outward. This may be achieved by expanding the horizontal beam832 which in turn pushes the side-arms outward. Alternatively, this maybe achieved by the side-arms 834 self-expanding which in turn expandsthe horizontal beam 832.

Another embodiment of the anchor 324, shown in FIGS. 27K-27L, involves athin disk 840 attached to the end of the suture 322. As shown in FIG.27K, the disk 840 may be rolled to a cylinder shape, for either mountingon the outside of or for insertion through a lumen in a needle, catheteror other introductory device. Upon delivery, as shown in FIG. 27L, thedisk 840 may then be flattened to provide a large surface area to restagainst the leaflets.

Another embodiment of the anchor 324, shown in FIGS. 27M-27N, involves asingle tubular structure 850, having longitudinal slits 852 from one endto approximately midsection, attached to the end of the suture 322. Asshown in FIG. 27M, the structure 850 may be compressed to a low profileposition so that it can be loaded within or on the outside of acatheter, needle or other delivery device. Upon delivery, as shown inFIG. 27N, the slit structure portions 854 may curl or bend outwardlyand/or downwardly. This provides a broad surface to rest against theleaflets.

Another embodiment of the anchor 324, shown in FIGS. 27P-27Q, involves atubular structure 860 attached to the end of the suture 322. As shown inFIG. 27P, the structure 860 may be mounted on the outside of a needle orintroductory device 862 in a low profile position. Upon delivery, asshown in FIG. 27Q, the structure 860 may compress longitudinally, as inan accordion-type fashion. In doing so, the structure 860 additionallyexpands radially to provide added surface area to rest against theleaflets.

Another embodiment of the anchor 324, shown in FIGS. 27R-27T, involves abar 870 attached to the end of the suture 322. As shown in FIG. 27R, thesuture 322 may rest flush against the bar 870 in a low profile positionfor loading within a needle, catheter or similar delivery device. Upondelivery, as shown in FIG. 27T, the bar 870 may reposition such that itis perpendicular to the suture line 322. In this way, the bar may restagainst the leaflet in an anchoring fashion. Referring to FIGS. 27U-27V,similar bars may be deployed from a double-barreled delivery device 880.As shown in FIG. 27U, a first bar 884 and a second bar 886 are loaded inparallel barrels separated by a partition 882. As shown in FIG. 27V, thefirst bar 884 may be deployed through the single lumen tip 888 of thedelivery device 882. The device 882 may then be repositioned at anotherlocation where the second bar 886 may be deployed in a similar fashion.

In an additional embodiment of the interventional tool 100, more thanone guide conduit 304 is present and directed at each leaflet forleaflet fixation. An example of such a tool 100 is shown in FIG. 28.Here the guide conduits 304 are shown attached to proximal elements 400in a radially protruded position. Interconnection of the proximalelements 400 with the guide conduits 304 may allow one to deploy theother. For example, deployment and advancement of the guide conduits 304angularly outward may draw the proximal elements 400 out from the shaft402 effecting their deployment. Alternatively, the proximal elements 400may be comprised of a material that is sufficiently rigid so thatdeployment of the proximal elements 400 draws the guide conduits 304downward and outward from the shaft 402 effecting their deployment. Theproximal elements 400 may also serve to position the guide conduits 304in a desired location. Distal elements 404 are also illustrated in aradially protruded position near the distal end 406 of the tool 100.

In use, the tool 100 is positioned between the valve leaflets LF, asshown in a top view in FIG. 29, so that the proximal elements 400 aredisposed against the atrial surface (in an atrial approach) of thevalve. The distal elements 404 are disposed against the ventricularsurface of the valve and thus are out of view. Such placement of theproximal elements 400 provides four target points 406 on the valveleaflet LF, two target points 406 per leaflet LF. Advancement of one ormore fixation tools through the guide conduits 304 allows placement ofsutures and optionally anchors 324 through the leaflets LF at the targetpoints 406 by the fixation tools. Once sutures and optionally anchors324 are placed through each of the target points 406, the sutures may bepulled together, cinched and fastened in place. FIG. 30 illustrates suchaction as the target points 406 will be drawn together in the directionof the arrows. This may provide a more sturdy and effective fixation ofthe leaflets and therefore repair of the valve.

Sutures 233 may be placed through each of the target points 406 by anumber of methods using a variety of fixation tools and devices. Forexample, FIG. 31 shows the placement of suture 233 through two adjacenttarget points 406 on one leaflet LF. Such illustrations assume an atrialapproach with a top view of the atrial surface of the leaflet LF asdepicted by shading. A first guide conduit 420 and a second guideconduit 422 protruding from the shaft 402 of an interventional tool 100are shown directed toward the target points 406. Through the first guideconduit 420 a needle 423 or other device may be used to penetrate theleaflet LF and deploy a snare 424 on the ventricular side of the leafletLF. Such a snare 424 may be comprised of any suitable material. Throughthe second guide conduit 422, a needle 423 or other device may be usedto penetrate the leaflet LF and deploy an anchor 426 through the snare424 on the ventricular side of the leaflet LF. Attached to the anchor426 is a suture line 233 which passes through the penetration at thetarget point 406 and continues up through the second guide conduit 422.The snare 424 is then retracted back through the needle 423 pulling theanchor 426 and attached suture line 233 with it. Thus, the anchor 426 isdrawn up through the first guide conduit 422 creating a continuoussuture line 233 through the second guide conduit 422, across theventricular surface of the leaflet LF and up through the first guideconduit 420. As shown in FIG. 32, this may be repeated on an adjacentleaflet LF and the suture lines 233 may be fixed together byconventional knot tying or any suitable method, including positioningfasteners. Although such fixation is shown with the sutures in a relaxedposition for clarity, such fixation will typically involve cinching theleaflets together so that the target points 406 are adjacent to oneanother.

It may be appreciated that the methods shown in relation to FIG. 31 maybe similarly performed across two adjacent leaflets LF, as illustratedin FIG. 33. Here, a needle 423 or other device may be used to penetratea leaflet LF and deploy a snare 424 on the ventricular side of theleaflet LF. Such a snare 424 may be comprised of any suitable material.Through the second guide conduit 422, a needle 423 or other device maybe used to penetrate the adjacent leaflet LF and deploy an anchor 426through the snare 424 on the ventricular side of the leaflet LF. Again,the anchor 426 is drawn up through the first guide conduit 422 creatinga continuous suture line 233 through the second guide conduit 422,across the line of coaptation C of the leaflet LF and up through thefirst guide conduit 420. This may be repeated on two or more additionaltarget points 406 in a similar manner and the suture lines 233 may befixed together by conventional knot tying or any suitable method,including positioning fasteners.

FIG. 34 illustrates a similar embodiment of an interventional tool 100having more than one guide conduit present and directed at each leafletfor leaflet fixation. This embodiment is used to place suture throughtarget points in a method similar to that described above in relation toFIGS. 31-33. However, this embodiment includes at least two slottedneedles 440 or similar devices having slots 442 or openings whichcontinue longitudinally from the needle 440 tip toward the shaft 443 fora desired distance. As shown, the tool 100 comprises a first, second,third and fourth guide conduit 451, 452, 453, 454 respectively. Throughthe first and fourth guide conduits 451, 454 needles 461 or otherdevices are introduced to penetrate the adjacent leaflets LF and deploysnares 456 on the ventricular side of the leaflets LF. Through thesecond and third guide conduit 452, 453 slotted needles 440 or otherdevice are introduced to penetrate the leaflets LF and deploy anchors458 through the snares 456 on the ventricular side of the leaflets LF.Attached to the anchors 458 is a continuous line of suture 459 whichruns between the anchors 458. The suture line 459 passes through thepenetrations at the target points 406, continues up through the slottedneedles 440, out of the slots 442, into a lumen or compartment withinthe catheter shaft 443 where it forms a loop. Such a suture line 459 isillustrated in FIG. 34. Thus, a continuous line of suture 459 runs fromone anchor 458 to another anchor 458 between adjacent leaflets LF. Theanchors 458 are then drawn up through the first and fourth guideconduits 451, 454 by retracting the snares 456. As shown in FIG. 35,this results in a continuous suture line 459 across the line ofcoaptation C on the atrial surface, between adjacent target points 406on the ventricular side surface of each leaflet LF and again across theline of coaptation C on the atrial surface where the free ends are fixedtogether by conventional knot tying or any suitable method, includingpositioning fasteners. It may be appreciated that the above describedmethod and device may be adapted to fix the leaflets together usingtarget points 406 in a variety of locations.

In another embodiment of the interventional tool 100, each guide conduit304 comprises a penetrating device or needle 340 having a suture holdingfeature 341, in this example notch, disposed near its distal end, asshown in FIG. 36. This type of fixation tool 305 is used in combinationwith a interventional tool 204 having a specific type of distal element302. This element 302 is similar to the loop 212 previously shown inFIG. 10A. As stated, these loops 212 are preferably made from nitinol orshape-memory wire, however other materials may be suitable. However, inthis case, the loops 212 are combined with a second set of loopscomprised of suture 342. The suture loops 342 are removably attached tothe inside surface of the loops 212. Such attachment may be provided bya number device features. For example, as shown in FIG. 37, the sutureloops 342 may be attached and held in place by heat shrink tubing 344over the loops 212. The heat shrink tubing 344 has perforations 345along the inside surface of the loop 212 to assist in release of thesuture loop 342 when desired. Alternatively, the suture loop 342 may beheld in place with a thin layer of material, such as polyurethane, whichis applied by dipping or spraying. The suture loop 342 may also beattached by a combination of heat shrink tubing 344 and liquidpolyurethane droplets in isolated sections. Further, as shown incross-section in FIG. 38, the loops 212 themselves may be extruded witha cavity 346 to house the suture 342. The suture 342 may be held inplace by the cavity 346 or by heat shrink tubing 344 and/or a layer ofmaterial such as polyurethane.

In any case, the interventional catheter 200 has fixation tools 305,comprising a needle 340 having a suture holding feature 341, and distalelements 302, comprising loops 212 combined with suture loops 342, asdescribed above. The guide conduits 304 are located proximal to thedistal elements 302 and are capable of extending angularly outward fromthe shaft 308 to protrude through the loops 212 and suture loops 342.FIG. 39 illustrates an atrial approach to the mitral valve. Theinterventional catheter 200 is positioned so that the distal element 302is deployed beyond the valve leaflet LF and one of the loops 212 ispressed against the ventricular surface of the leaflet LF (shadingillustrates its planar surface demarked by a leaflet edge 350). It maybe appreciated that although the catheter 200 is illustrated to sutureone leaflet, the catheter 200 will typically comprise a duplicatearrangement symmetrically positioned on the opposite side of the shaft308 to additionally suture the other leaflet. Only one leaflet LF isshown for clarity. The needle 340 is advanced toward the leaflet LFeither by extension of the guide conduit 304 or the needle 340 itself.In either case, the needle 340 is then advanced to penetrate the leafletLF and emerge from the other side or the distal side of the leaflet .The penetration hole 352 illustrates the point of entry through theleaflet LF. The needle 340 is further advanced so that the sutureholding feature 341 is disposed in the same plane as the suture loop342. As shown in FIG. 40, the suture loop 342 is then retracted so thatit is released from the heat shrink tubing 344 and is disposed withinthe suture holding feature 341. The needle 340 is then retracted, asshown in FIG. 41, pulling the suture loop 342 through the penetrationhole 352 to the atrial side of the valve. To aid in maintaining thesuture loop 342 within the suture holding feature 341, a sheath ortubing may be slid over the suture holding feature 341 to hold thesuture loop 342 in place. The other leaflet LF of the mitral valve ispierced in the same manner wherein the suture loop is threaded to theatrial side of the valve. The suture loops are then fixed together byconventional knot tying or any suitable method, including positioningsuture fasteners.

V. DEVICE EMBODIMENTS. The following device embodiments depict completedevice designs utilizing a variety of the specific features describedabove. In addition, new features are also introduced which provideadditional device capabilities. The embodiments shown are designed fortreatment of the mitral valve with an atrial approach. However, it maybe appreciated that the design features may be adapted for other valvesand other approaches.

The embodiments of the interventional catheter 500 will be described inconjunction with its method of use for repairing a regurgitive mitralvalve. However, the device will be illustrated independently of thevalve anatomy to more clearly illustrate the workings of the device. Therelationship of the device to the valve anatomy throughout the steps ofthe method may be easily visualized based on description.

In the first embodiment, referring to FIG. 42, the interventionalcatheter 500 comprises an elongate shaft 502 having at least one capturedevice 504 and guide conduit 506 disposed near its distal end 508. Thecapture device 504 comprises distal loops 510 which are located near thetip 512 of the catheter. Two distal loops 510 are shown, one on eachside of the catheter 500, for the capturing of two valve leaflets. Thedistal loops 510 are retracted for introduction of the catheter 500through a previously placed guidecatheter. Proximal loops 514 and guideconduits 506 are also shown. Since both the proximal loops 514 and theguide conduits 506 are located proximal to the distal loops and approachthe atrial surface of the leaflets, they may be interconnected at theguide conduit cuff 516 as shown. In addition, such interconnectivity mayprovide advantages which have been presented earlier in relation toembodiments having similar interconnectivity. It may be appreciated,however, that these features may be independent in other embodiments.Similar to the distal loops 510, the proximal loops 514 and guideconduits 506 are retracted for introduction of the catheter 500 throughthe previously placed guidecatheter. In addition, portions of thecatheter 500 may have an integral spring or flexible section 516 whichmay assist in passing the device through any curves in the guidecatheterduring introduction.

After introduction, the catheter 500 is advanced so that the tip 512 ofthe catheter is positioned within the atrium, above the mitral valve.Referring to FIG. 43, the distal loops 510 are then deployed so thatthey protrude radially outward from the shaft 502. The device is thenoriented so that the distal loops 510 are positioned substantiallyperpendicular to the line of coaptation between the two valve leaflets.This may be accomplished with the use of short-axis echocardiography.The tip 512 may be moved roughly along the line of coaptation to thelocation of regurgitation. After alignment, the tip 512 and distal loops510 are advanced through the valve, between the leaflets, so that theloops 510 emerge beyond the valve. Perpendicular alignment is thenreconfirmed using echocardiography. At this point, the distal end 508 isretracted so that the distal loops 510 move upward, toward the atrium,and press against the ventricular surface of the leaflets. This graspsthe leaflets and holds the leaflets in place throughout the cardiaccycle. During diastole, a double orifice geometry may be visualizedusing short-axis echocardiography, as previously shown in FIG. 5.

Referring to FIG. 44, the proximal loops 514 and guide conduits 506 areco-deployed and advanced toward the atrial surface of the leaflets. Aspreviously described, interconnection of the proximal loops 514 with theguide conduits 506 may allow one to deploy the other. For example,deployment and advancement of the guide conduits 506 angularly outwardmay draw the proximal loops 514 out from the shaft 502 effecting theirdeployment. Alternatively, the proximal loops 514 may be comprised of amaterial that is of sufficient rigidity so that deployment of theproximal loops 514 draws the guide conduits 506 downward and outwardfrom the shaft 502 effecting their deployment. The proximal loops 514may also serve to position the guide conduit cuffs 516 within the distalloop 510 as shown.

In any case, as shown in FIG. 45 in a side-view, the proximal loops 514and guide conduits 506 are deployed to near or below the plane of thedistal loops 510 so that they are in contact with the atrial surface ofthe leaflets. Although not illustrated, the valve leaflets would residebetween the proximal loops 514 and the distal loops 510. In some cases,such as in severe prolapsing valves, the proximal loops 514 may bedeployed prior to grasping the leaflets with the distal loops 510. Inthese cases, the proximal loops 514 may act to limit the extent ofprolapse and to assist in trapping the leaflet between the proximal anddistal loops.

Once the leaflets are securely grasped between the proximal and distalloops, the double orifice geometry is confirmed during diastole usingshort-axis echocardiography. If the positioning of the leaflets appearsas desired, piercing devices or needles 520 are advanced from the guideconduit cuffs 516 to puncture and penetrate the valve leaflets. As shownin FIG. 46, the needles 520 are advanced through the distal loops 510 sothat the distal loops 510 may support the leaflet during penetration. Asshown in FIG. 47, the distal loops 510 are then retracted, pulling theneedles 520 radially toward the shaft 502. Since each needle 520 ispierced through a leaflet, the radially inward movement of the needles520 draws the leaflets together at the points of penetration. Thissimulates the methods of performing a standard surgical bow-tie repair.At this point, the proximal loops 514 may be removed from the valvesurface and the mitral regurgitation may be evaluated to determine ifthe two pierced points are suitable for fixing the leaflets together.Color Doppler echo will show if the regurgitation of the valve has beenreduced. If the resulting mitral flow pattern is satisfactory, theleaflets may be fixed together in this orientation. If the pattern isunsatisfactory, the above steps may be repeated until a satisfactoryflow pattern is obtained.

Referring to FIG. 48, fixation may be achieved with the use of fixationpledgets or anchors 522 which are deployable from the needles 520. Pushrods (not shown) may be advanced within the needles 520 to deploy theanchors 522 from the needles 520. Attached to each anchor 522 is a lineof suture 524 which is captured within each needle 520, as shown. Theneedles 520 are then retracted back through the leaflet penetrations,leaving the anchors 522 on the ventricular side of the valve leafletswhile threading the suture 524 through the penetrations. Simultaneouslyor subsequently, the tip 512 and/or distal end 508 is advanced distallyto position the distal loops 510 slightly below the anchors 522. In thisway, the distal loops 510 may be retracted inwardly without trapping thelines of suture 524 in the loops 510. The distal loops 510 are thusretracted to a low profile position and the proximal loops 514 and guideconduits 506 are also retracted to their original low profile position.As shown in FIG. 49, the distal end 508 is then withdrawn from thevalve, leaving the anchors 522 disposed on the ventricular side of theleaflets LF and the lines of suture 524 threaded through thepenetrations 526, continuing up through the guide conduits 506.

Referring to FIG. 50, a holding tube 530 containing the free ends ofboth sutures 524 is separated from the shaft 502 and advanced toward theatrial surface of the leaflets LF. This holds tension on the anchors 522to maintain the position of the anchors 522 against the ventricularsurface of the leaflets LF and to maintain the coaptation of theleaflets LF along the line of coaptation C. A suture fixation devicedeployment catheter (not shown) is then inserted through, over orreplacing the holding tube 530 to tie the sutures together with a knotor to deploy a fixation device 532 to hold the sutures 524 in place, asshown in FIG. 51. A suture cutter (not shown) is integral with thedeployment catheter and is used to cut the suture lines 524 proximal tothe fixation device 532. The deployment catheter is then removed leavingthe fixed leaflets in a repaired condition.

In the second embodiment, referring to FIG. 52, the interventionalcatheter 1050 comprises an elongate shaft 1052 and a detachable capturedevice 1054. The capture device 1054 comprises, among others, proximalelements 1056 and distal elements 1058. Such a capture device 1054 issimilar to that presented in FIGS. 17C-17D. Again, the proximal elements1056 may be separately deployable from the distal elements 1058. Asshown, the distal elements 1058 are deployed so that they are extendedradially outward from the shaft 1052. The proximal elements 1056 may beheld against the shaft by sutures 1060 which are drawn up within theshaft 1052. In this orientation, the catheter 1050 may be manipulatedbetween the leaflets so that the distal elements 1058 are positionedagainst the ventricular surface of the valve leaflets LF.

Referring to FIG. 53, the proximal elements 1056 may then be released byslacking the sutures 1060. This allows the preformed elements 1056 toextend radially outward and downward, as illustrated. Depending on thecurvature of the proximal elements 1056, they may remain proximal to,move to within the same plane of, or move beyond the plane of the distalelements 1058. Here, the proximal elements 1056 are shown slightlybeyond the plane of the distal elements 1058. Thus, the leaflets LFwould be grasped and held in place between the elements 1056, 1058. Inaddition, the proximal elements 1056 include prongs 1057 to providefriction and assist in holding the leaflets LF.

The leaflets LF may then be repositioned by manipulating the elements1056, 1058 while the leaflets LF are grasped therebetween. Referring toFIG. 54, the elements 1056, 1058 may be drawn inward by rotation of atorque shaft 1064, such rotation indicated by an arrow. Rotation of thetorque shaft 1064 drives a screw 1065 in the capture device 1054 whichtranslates a nut 1066 downward within the capture device 1054. Thetranslating nut 1066 draws the elements 1056, 1058 inward to assist incoaptation of the leaflets LF.

FIG. 55 more closely illustrates the workings of the capture device1054. The nut 1066 is positioned on the screw 1065 between a topstructure 1068 and a bottom structure 1069. The proximal and distalelements 1056, 1058 are fixedly attached in holes 1076 in the nut 1066and pass through holes 1074 in the top structure 1068. The screw 1065has a screw top 1070 which extends into a torque driver 1072. The innerdiameter of the driver 1072 is square to receive the square screw top1070. The torque shaft 1064 is attached to the driver 1072 so thatrotation of the shaft 1064 rotates the screw 1065. This in turntranslates the nut 1066 downward, drawing the elements 1056, 1058 inwardthrough the holes 1074. Since the nut 1066 has flat sides, the nut 1066will not rotate within an outer casing 1076 (shown in FIG. 54) whichfits against the nut 1066.

During repositioning of the leaflets LF, imaging is used to verify thatcoaptation and mitral regurgitation reduction is suitable. Once theleaflets LF are suitably positioned, the capture device 1054 is readyfor detachment. FIGS. 56-57 illustrate an embodiment of the detachmentmechanism which is similar in design and function to that previouslydescribed in relation to FIGS. 21D-21E. FIG. 56 illustrates a tubularupper shaft 1080 and a detachable lower shaft 1082 which are interlockedat a joining line 1084. Again, the joining line 1084 may have any shapeor curvature which will allow or facilitate interlocking and laterdetachment. The torque driver 1072 bridges the joining line 1084 asshown. Such placement of the driver 1072 prevents twisting andtranslation of the upper and lower shafts 1080, 1082. FIG. 57illustrates detachment of the lower shaft 1082 from the upper shaft1080. This is achieved by retracting the driver 1072 to a position abovethe joining line 1084 which in turn allows the shafts 1080, 1082 toseparate. Consequently, the capture device 1054 is detached from theshaft 1052 of the interventional catheter 1050, as shown in FIG. 58, andleft behind as an implant to hold the leaflets LF in the desired coaptedposition.

Kits 1000 according to the present invention comprise any number ofitems related to the devices, systems and methods described above. Asshown in FIG. 59, such kits 1000 typically include at least oneinterventional catheter 1002 having a capture device 1004. Optionally,the capture device 1004 may be detachable and, in such a case, a numberof capture devices 1004 (or fixation devices) may be included in the kit1000. The kits 1000 also include instructions for use IFU setting forthany of the methods according to the present invention. Optionally, thekits 900 may further include any of the other system componentsdescribed above, such as one or more guidecatheters 1006, guide wires1008, dilators 1009, penetration devices 1010, sutures 1012, anchors1014 optionally having sutures 1012 attached, snares 1016 optionallyhaving sutures 1012 attached, and fasteners 1018 to fix suturestogether, to name a few. Some or all kit components will usually bepackaged together in a pouch 1020 or other conventional medical devicepackaging. Usually, those kit components which will be used inperforming the procedure on the patient will be sterilized andmaintained within the kit. Optionally, separate pouches, bags, trays orother packaging may be provided within a larger package, where thesmaller packs may be opened separately to separately maintain thecomponents in a sterile fashion.

Although the foregoing invention has been described in some detail byway of illustration and example, for purposes of clarity ofunderstanding, it will be obvious that various alternatives,modifications and equivalents may be used and the above descriptionshould not be taken as limiting in scope of the invention which isdefined by the appended claims.

What is claimed is:
 1. A method for repairing a cardiac valve havingvalve leaflets, the method comprising: advancing a catheter having acapture device through an atrium of the heart to a location near thecardiac valve, wherein the capture device comprises at least oneproximal element and at least one distal element adapted to protruderadially outward; holding the at least one proximal element upward by asuture; extending the at least one distal element radially outward afteradvancing the capture device to the location near the cardiac valve ofthe heart; atraumatically positioning the at least one distal elementagainst at least one leaflet of the cardiac valve; releasing the atleast one proximal element by slacking the suture to allow the at leastone proximal element to extend radially outward to capture the at leastone leaflet between the at least one proximal element and the at leastone distal element; and detaching the capture device from the catheter.2. The method of claim 1, wherein advancing the catheter comprisesadvancing the catheter through the inferior vena cava or the superiorvena cava to the atrium of the heart.
 3. The method of claim 2, whereinadvancing the catheter further comprises advancing the catheter acrossan interatrial septum.
 4. The method of claim 1, wherein advancing thecatheter across an interatrial septum comprises piercing the interatrialseptum.
 5. The method of claim 1, wherein the cardiac valve is a mitralvalve.
 6. The method of claim 1, wherein the at least one distal elementincludes a pair of distal elements and the at least one proximal elementincludes a pair of proximal elements.
 7. A capture device for repairinga cardiac valve having valve leaflets, the device comprising: at leastone distal element adapted to be extended radially outward after thecapture device is advanced to a location near the cardiac valve of theheart, the at least one distal element being configured to beatraumatically positioned against at least one leaflet of the cardiacvalve; at least one proximal element held upward by a suture, whereinthe at least one proximal element has a bias configured to extendradially outward when the suture is slacked to enable capture of the atleast one leaflet between the at least one proximal element and the atleast one distal element; and a detachment mechanism configured todetach the capture device from a catheter.
 8. The capture device ofclaim 7, wherein the at least one distal element incudes a pair ofdistal elements, and the at least one proximal element includes a pairof proximal elements.